(280 days)
The Breeze Scooter is intended to provide increased mobility for the elderly and/or disabled persons. It is an aid to independent living. The Breeze does not provide treatment for any ailment, nor does it have diagnostic capability. The Breeze is also suite for the use of elderly persons and physically disabled persons.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Breeze," a motorized three-wheeled vehicle (scooter) manufactured by Afikim Electric Vehicles. This letter grants clearance for the device based on its substantial equivalence to a legally marketed predicate device, but it does not contain any information about acceptance criteria, device performance studies, or ground truth establishment.
The document states:
- Device Name: Breeze
- Regulation Number: 21 CFR 890.3800
- Regulation Name: Motorized three-wheeled vehicle
- Regulatory Class: II
- Product Code: INI
- Indications for Use: "The Breeze Scooter is intended to provide increased mobility for the elderly and/or disabled persons. It is an aid to independent living. The Breeze does not provide treatment for any ailment, nor does it have diagnostic capability. The Breeze is also suitable for the use of elderly persons and physically disabled persons."
Since this document is simply an FDA clearance letter, it does not include the detailed technical study information you are requesting. Such information would typically be found in the 510(k) submission itself, which is a much more extensive document. Therefore, I cannot provide the requested details about acceptance criteria, performance studies, sample sizes, ground truth, or expert qualifications based on the provided text.
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Public Health Service
JAN 2 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Avner Fishbein Afikim Electric Vehicles Kibbutz Afikim, 15148 Israel
Re: K051028 Trade/Device Name: Breeze Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: December 15, 2005 Received: December 19, 2005
Dear Mr. Fishbein:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indictions for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control (Sections 531-542 of the Act); 21 CFR 1 all II applicane, the elections
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Page 2 - Mr. Avner Fishbein
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results of basification for your device on your device to alegally
to proceed to the market to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the Division of Small
(301) 442-6507 and its Late Late Lonsumer Assistance at its toll-free number (800) 638-(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html
Sincerely vours.
2
f
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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AFIKIM ELECTRIC VEHICLES Kıbbutz Alikim 15148, İsrael Tel: + 972 - 4 - 6: 7 5 4 8 1 4 Fax: + 9 7 2 - 4 - 6 7 5 1 4 5 6 E-mail; mainbox@atiscoolers.com
January 16 2006 Page 1 of 1
Indications for Use
510(k) Number (if known): K051028
Device Name: Breeze
Indications for Use:
The Breeze Scooter is intended to provide increased mobility for the elderly and/or disabled persons. It is an aid to independent living. The Breeze does not provide treatment for any ailment, nor does it have diagnostic capability.
The Breeze is also suite for the use of elderly persons and physically disabled persons.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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タミやにらんす
Over-The-Counter Use V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).